Product code HKK— Ophthalmic

DUALENZ LOW VISION EYEWEAR

Classification name: Telescope, Spectacle, Low-Vision
Device class: Class 1
Regulation: 21 CFR 886.5870
Advisory panel: Ophthalmic
Total cleared: 2
First cleared: 1987-01-20
Most recent: 1987-02-12

Market context for product code HKK

FDA has cleared 2 devices under product code HKK, all in 1987, filed by 2 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code HKK

Keeler Instruments, Inc.1 clearance
Global Eye Care, Inc.1 clearance

Recent clearances under product code HKK

K870203 — KEELER LVA SYSTEM MULTI-CAP SERIES LVA51-1/2/3/4/5Keeler Instruments, Inc.·1987-02-12
K864594 — DUALENZ LOW VISION EYEWEARGlobal Eye Care, Inc.·1987-01-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.